Kornimate/medical-research-clean huggingface dataset:
adjunctive bright light therapy in adolescents with depression and eveningness

Conditions: Depression, Unipolar

Summary: this study examines the efficacy of bright light therapy as a treatment for adolescents diagnosed with unipolar non-seasonal depression who exhibit an evening chronotype.

this randomized, placebo-controlled, assessor-blinded trial aims to evaluate the efficacy of bright light therapy (blt) as a treatment for adolescents with depression and evening chronotype. eligible participants will be randomized to receive either blt or dim red light (placebo) daily for 8 weeks. depression severity, sleep parameters, and circadian markers will be assessed at baseline, during treatment, post-treatment, and at follow-up visits.

Eligibility criteria:
inclusion criteria: 1. chinese, aged 12-19 years old; 2. written informed assent/consent of participation into the study is given by the participant and his/her parent or guardian (for those aged under 18), respectively; 3. having a dsm-5 diagnosis of unipolar non-seasonal depression as confirmed by the chinese version of the kiddie-schedule for affective disorders and schizophrenia (k-sads) psychiatric interview, dsm-5 seasonal specifier, and having a score on children's depression rating scale (cdrs-r) at least 40; 4. being classified as evening chronotype according to the score on the reduced horne-östberg morning-eveningness questionnaire (rmeq), i.e. \<12. exclusion criteria: 1. a current diagnosis of substance abuse or dependence; a current or past history of manic or hypomanic episode, schizophrenia spectrum disorders, organic mental disorders, or intellectual disabilities; 2. having a clinically significant suicidality (presence of suicidal ideation with a plan or an attempt) as assessed by k-sads; 3. having been enrolled in any other clinical trial investigational products within one month at the entry of the study; 4. initiation of or change in antidepressant medication within past 4 weeks; 5. having been or is currently receiving any structured psychotherapy; 6. with hearing or speech deficit; 7. night shift worker; 8. trans-meridian flight across at least two time zones in the past 3 months and during the study; 9. presence of an eye disease, e.g., retinal blindness, severe cataract, glaucoma.

Keywords: depression eveningness bright light therapy adolescents
a prospective open-label study of aripiprazole in fragile x syndrome

Conditions: Fragile X Syndrome

Summary: the purpose of this study is to determine the effectiveness and tolerability of aripiprazole in the treatment of children and adolescents with fragile x syndrome.

this 12-week prospective, open-label study design was chosen to gather pilot data for potential future lager scale, double-blind, placebo-controlled studies in fragile x syndrome. we hypothesize that aripiprazole will be effective in decreasing aggression, sib, agitation, and interfering repetitive behavior commonly observed in individuals with fragile x syndrome. we also hypothesize that aripiprazole will be well tolerated.

Eligibility criteria:
inclusion criteria: 1. males and females between the ages of 5 and 35 years and 2. body weight greater than or equal to 15 kg 3. confirmed diagnosis of fragile x syndrome based upon genetic testing results. 4. outpatients. 5. psychotropic medication-free for at least 2 weeks prior to screening laboratory tests and electrocardiogram. (except 5 weeks for fluoxetine and 4 weeks for all typical and atypical antipsychotics that have been administered for at least a 4 week period.) exceptions to medication-free status will include drugs given at bedtime targeting insomnia. such drugs may include melatonin, clonidine, chloral hydrate, diphenhydramine, ramelteon, benzodiazepines, or other sedative-hypnotics. 6. clinical global impression scale severity score (cgi-s) of at greater than or equal to 4 (moderately ill) 7. a score of at greater than or equal to 18 on the irritability subscale of the aberrant behavior checklist (abc) at screen and baseline. 8. mental age of greater than or equal to 18 months as measured by the wechsler, revised leiter, or mullen tests 9. each subject must be in good physical health as determined by screening procedures which will include a detailed medical history, complete physical and neurological examination. exclusion criteria: 1. dsm-iv diagnosis of schizophrenia, another psychotic disorder, bipolar disorder or alcohol or other substance abuse within the last 6 months. 2. a significant medical condition such as heart, liver, renal or pulmonary disease, or an actively treated seizure disorder, as determined by history, physical examination or laboratory testing. 3. subjects with an unstable seizure disorder will be excluded. 4. females with a positive urine pregnancy test. 5. evidence of a prior adequate trial of aripiprazole (defined as a duration of greater than or equal to 2 weeks at a dose of at least 5 mg per day). when there is not evidence of a prior adequate trial of aripiprazole, subjects must be medication-free for at least 2 weeks prior to baseline. 6. evidence of hypersensitivity to aripiprazole (defined as an allergic response \[e.g., skin rash\] or potentially serious adverse effect \[e.g., significant tachycardia\]). 7. history of neuroleptic malignant syndrome. 8. subjects who, in the opinion of the investigator, are unsuitable in any other way to participate in this study including being unable to comply with the requirements of the study for any reason.
prophylactic antibiotics or placebo after hypospadias repair

Conditions: Hypospadias

Summary: the primary purpose of this study is to determine if routine use of prophylactic (preventive) antibiotics after repair of mid-to-distal hypospadias is beneficial.

participants in this multicenter, double-blind study are randomized to receive trimethoprim-sulfamethoxazole or placebo for 10 days postoperatively. short- and intermediate-term results will be published after participants complete 6 months and 5 years of follow-up, respectively.

Eligibility criteria:
inclusion criteria: * mid-to-distal shaft hypospadias * single-stage hypospadias repair * length of urethral repair (urethroplasty) less than or equal to 20 mm * placement of an open-drainage urethral stent at the time of hypospadias repair, with intended duration of stenting for 5-10 days post-operatively exclusion criteria: * previous hypospadias repair * prior adverse/allergic reaction or other contraindication to trimethoprim-sulfamethoxazole * cross-reactivity of an existing medication with trimethoprim-sulfamethoxazole * any patient condition with elevated risk of infection or adverse outcome from potential infection (e.g., hiv/aids, poorly controlled diabetes mellitus or other immunocompromising conditions, congenital heart disease) * use of antibiotics within seven days prior to hypospadias repair * foreskin reconstruction at the time of hypospadias repair * prescription of oral antibiotics other than study medication at the time of hypospadias repair

Keywords: hypospadias anti-bacterial agents
influence of preoperative support on anxiety, pain and satisfaction with postoperative analgesia

Conditions: Pain, Postoperative; Surgery, Thoracic

Summary: the aim of this study was to analyze a relationship between information support provided by an interdisciplinary team and the levels of anxiety, pain and satisfaction with postoperative analgesia in children and adolescents subjected to thoracic surgeries.

the study included 112 consecutive pediatric patients qualified for lateral thoracotomy or ravitch procedure. the subjects were randomized to the control group (n=56) provided with a routine preoperative information from a nurse, and the experimental group (n=56) offered additional psychological consultation.

Eligibility criteria:
inclusion criteria: * thoracic surgery (lateral thoracotomy or ravitch procedure), * the american society of anesthesiologists score 1 or 2. exclusion criteria: * presence of a mental disorder, * anticancer treatment, * preoperative pain, * problems with verbal communication , * lack of postoperative drainage of the chest.

Keywords: anxiety preoperative education psychologist thoracotomy ravitch procedure postoperative pain
instrumental activities of daily living approach in home environment for patients with stroke

Conditions: Stroke; Activities of Daily Living

Summary: the purpose of this study was to conduct a randomized clinical trial. implement instrumental daily activities of daily living (a-iadl) in home rehabilitation. to explore the effect of a-iadl on stroke patients' movement, cognition, social participation, daily life function and quality of life.

subjects were randomized to intervention group and control group. the experiment was designed as randomized cross-over control trial. the primary outcome included 11 measures, fugl-meyer assessment, balance computerized adaptive testing, mini mental state examination, participation measure-3 domains ,4 dimensions, canadian occupational performance measure, barthel index-based supplementary scales, frenchay activities index, lawnton instrumental activities of daily living, stroke impact scale, stroke self-efficacy questionnaire, and kingston caregiver stress scale.

Eligibility criteria:
inclusion criteria: * age \> 20 years * diagnosis of stroke * the modified rankin scale : 2\~4 * keep sitting for half an hour by himself/herself * follow instructions * willing to sign the subject's consent exclusion criteria: * diagnosis of dementia * history of orthopedic diseases or peripheral nerve injury

Keywords: stroke activities of daily living home care services
preemptive lung impedance-guided therapy of evolving acute heart failure in acute myocardial infarction patients

Conditions: Acute Heart Failure

Summary: it is well known that 20-25% of patients hospitalized for acute myocardial infarction will develop acute heart failure during their hospitalization. currently, the investigators have no reliable parameter for prediction of evolving acute heart failure in such a group of patients. as a result, the investigators have no way of preventing acute heart failure. treatment of these patients only begins after appearance of clinical signs of acute heart failure. lung impedance monitoring may be a good non-invasive parameter for prediction of evolving acute heart failure. this study will attempt to address whether preemptive lung impedence-guided therapy may prevent the development of overt acute heart failure and improve their clinical outcome.


Eligibility criteria:
inclusion criteria: * patients hospitalized in the iccu for acute myocardial infarction and developing acute heart failure during their hospitalization exclusion criteria: * patients with acute myocardial infarction with clinical and radiological signs of acute heart failure at admission

Keywords: developing acute heart failure
brivaracetam safety and efficacy follow-up study in subjects with epilepsy

Conditions: Epilepsy

Summary: this is a phase 3, open label, long term follow-up (ltfu), multicenter, noncomparative, and single arm study of brivaracetam (brv).

the primary objective is to evaluate the long term safety and tolerability of brv at individualized doses up to a maximum of 200 mg/day in epilepsy subjects.

Eligibility criteria:
inclusion criteria: * subject completed the treatment period of n01358 or the evaluation period of n01258 * male/female subject from 16 years or older. subject under 18 years may only be included where legally permitted and ethically accepted * subject for whom the investigator believes a reasonable benefit from the long term administration of brv may be expected * female subject without childbearing potential (premenarcheal, postmenopausal for at least 2 years, bilateral oophorectomy or tubal ligation, complete hysterectomy) are eligible exclusion criteria: * subject has developed hypersensitivity to any components of the investigational medicinal product (imp) or comparative drugs as stated in this protocol during the course of the core studies * severe medical, neurological, or psychiatric disorders, or laboratory values which may have an impact on the safety of the subject * poor compliance with the visit schedule or medication intake in the previous brv study * planned participation in any other clinical study of another investigational drug or device during this study * pregnant or lactating woman * any medical condition which, in the investigator's opinion, warrants exclusion * subject has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months

Keywords: epilepsy brivaracetam partial onset seizures adjunctive treatment
evaluating the implementation of a comprehensive multilevel virtual oncology program among veterans diagnosed with lung, colorectal, prostate, and breast cancers in the us department of veterans affairs

Conditions: Lung Cancer Diagnosis; Colorectal Cancer (Diagnosis); Prostate Cancer Diagnosis; Breast Cancer Diagnosis

Summary: the purpose this pragmatic trial to test the effectiveness of an existing, ongoing clinical service, the va national teleoncology program (nto), a multilevel telehealth population health management program. the primary aims are to study the intervention and determine its effectiveness on telehealth engagement, clinical quality, and healthcare cost outcomes across levels of social determinants of telehealth (sdth) with the goal of promoting health equity.

study staff will use the veterans health information systems and technology architecture (vista), the va health information technology system, to identify eligible patients at va sites based on listed inclusion and exclusion criteria. patient records will be observed of veterans with a new cancer diagnosis of the lung, prostate, breast, or colon and a telehealth visit utilizing the va national teleoncology service (nto).

Eligibility criteria:
patients inclusion criteria: 1. a veteran 2. aged 18 years or older 3. newly diagnosed with lung, prostate, breast, or colon cancer within 3 months of telemedicine visit 4. engaged in an oncology visit during the 36-month analysis period at a veterans affairs medical center (vamc) location. vamc providers and staff inclusion criteria: 1. provider or staff member at one of the vamc locations including physicians, nurse practitioners, physicians' assistants, and nurses caring for veterans 2. providers or staff members having helped provide care for at least 5 veterans with cancer in the previous 6 months at a vamc location patients exclusion criteria: 1. veterans who have not seen any providers in the va within the past year 2. patients previously diagnosed with lung, prostate, breast, or colon cancer 3. pregnant patients vamc providers and staff exclusion criteria: 1. providers or staff members who do not help treat veterans with specified cancers in oncology at the va
patient satisfaction and complications with the new titan® one touch release (otr) penis prosthesis

Conditions: Erectile Dysfunction; Intraoperative Complications; Postoperative Complications

Summary: the purpose of this study is to assess patient satisfaction with the titan one touch release penis prosthesis and to register complications with this prosthesis. this will regard the first prostheses inserted at herlev hospital/frederikssund hospital. patient satisfaction will be assessed by mailing out the "erectile dysfunction inventory of treatment satisfaction (edits) questionnaire" and recording the patient answers. the most important question will be "overall how satisfied are you with penile prosthesis?". complications (including infection, bleeding, and mechanical failure) will be assessed by a patient chart review and confirmed by a brief phone interview.


Eligibility criteria:
inclusion criteria: * men who have had a titan one touch release penis prosthesis implanted at herlev hospital. exclusion criteria: * inability to read danish

Keywords: penis prosthesis titan satisfaction complications
evaluate the efficacy and safety of proso millet and wheat extract(keranat™) on hair health

Conditions: Hair Damage

Summary: the purpose of this randomized, double-blind, placebo-controlled study will be to evaluate whether the daily intake of keranat™ for 24 weeks can promote the gloss and elasticity of hairs, improve their density and strength, and reduce hair loss.


Eligibility criteria:
inclusion criteria: * age 19 and 60 * hair gloss score of 3 or less and a hair damage score of less than 18 according to the visual evaluation classification method. * willing to maintain the same hairstyle, hair color, hair length, and hair regimen throughout the study period. * subject must be able to comprehend and voluntarily sign study procedures and consent forms. exclusion criteria: * those diagnosed with and receiving treatment for the alopecia within 3 months before screening(androgenetic alopecia, alopecia areata, telogen effluvium, etc.) * use of that may affect hair or hair loss symptoms treatment medicine, dietary supplements, or treatments containing herbal medicine ingredients within 3 months before screening. * any active scalp or skin disease that may interfere with the study treatment and evaluations. * pregnancy or breastfeeding or planning pregnancy * case of abnormal values at creatinine (excess at the upper limit of the reference range) * case of abnormal values at alt or ast (2 times excess at the upper limit of the reference range)

Keywords: hair gloss hair elasticity hair strength hair thickness anagen hair number of hair loss
rivaroxaban as thrombosis prophylaxis in bariatric surgery

Conditions: Bariatric Surgery

Summary: the aim of this study is to investigate the efficacy and safety of rivaroxaban in obese patients undergoing bariatric surgery. the objectives are to assess the safety and feasibility of venous thromboembolism (vte) prophylaxis and lung embolism with rivaroxaban 10mg as an oral anticoagulant. after bariatric surgery patients receive the study medication xarelto 10mg qd for 7, resp. 28 days. all clinically thromboembolic events will be assessed by ultrasound or ct, respectively, as soon as apparent. in addition, patients are screened for vte at day 28 by ultrasound to detect clinically inapparent thromboses. in a subgroup of study patients (patients from the university hospital inselspital, bern) pk/pd parameters are assessed following the last intake of rivaroxaban at day 28.

the aim of this study is to investigate the efficacy and safety of rivaroxaban in obese patients undergoing bariatric surgery. rivaroxaban as an oral anticoagulant could be an attractive option for thromboprophylaxis compared to subcutaneous standard treatment after bariatric surgery. especially in high-risk patients where an extended duration of thromboprophylaxis after hospital discharge is recommended, an oral therapy would be desirable. the objectives are to assess the safety and feasibility of vte prophylaxis and lung embolism with rivaroxaban 10mg as an oral anticoagulant. especially in high-risk patients where an extended duration of thromboprophylaxis after hospital discharge is recommended, an oral therapy would be desirable. after bariatric surgery patients receive the study medication xarelto 10mg qd for 7, resp. 28 days. in a subgroup of study patients (patients from the university hospital inselspital, bern) pk/pd parameters are assessed following the last intake of rivaroxaban at day 28.

Eligibility criteria:
inclusion criteria: * patients with scheduled elective bariatric surgery or redo surgery after bariatric interventions * written informed consent exclusion criteria: * dvt and/or pe in the patient history * myocardial infarction, transient ischemic attack or stroke within 6 months of study entry * uncontrolled hypertension

Keywords: rivaroxaban thromboembolic prophylaxis venous thromboembolism
effectiveness of smartphone application for adherence support (vuka+)

Conditions: Adherence, Medication; Smartphone Application

Summary: this is a type i hybrid effectiveness-implementation trial to evaluate an hiv pre-exposure prophylaxis (prep) medication adherence, persistence and social support app (vuka+) for adolescent girls and young women (agyw) in south africa. this 6-month, 2-arm effectiveness and implementation trial (standard of care \[soc\] vs. intervention app) will assess acceptability, feasibility and effectiveness. in addition, we will gather information on intervention delivery and barriers and facilitators for real-world delivery to inform future implementation and scale up.

we will recruit 330 agyw, aged 15-24 from the surrounding community, prep clinics and service providers in cape town, south africa. if agyw qualify for enrollment, they will be offered daily truvada as prep. participants will then be randomized 1:1 at baseline to soc counselling and the vuka+ intervention app or soc counselling only (control). all participants will receive their regularly scheduled prep clinical care visits. at baseline, 1-, 3- and 6-month follow-up visits, participants will complete biobehavioral surveys, undergo hiv testing and pregnancy testing, and provide a urine (month 1 and 6) and dbs sample (months 1, 3 and 6) for tenofovir assessment. intervention arm participants will also have the following study activities: install the intervention app on their phones at baseline study visit and be asked to use the intervention app for at least 5-10 minutes daily for 6 months. during this time, they will be prompted by the app to complete daily activities or health and wellness readings and to complete a weekly brief assessment related to their prep use. at follow-up study visits, intervention arm participants will complete an additional set of questions evaluating their app use experience and a subsample of participants will complete an in-depth qualitative exit interview to assess their app use experience, acceptability of the intervention and their evaluation of the app's content.

Eligibility criteria:
inclusion criteria: * assigned female at birth * age 15-24 years * healthy and weight at least 35kg * sexually active (had a male sexual partner in the past 6 months) * consistent access to a smartphone * hiv-negative (clinic test) * prep naive or no prep use in the past 6 months * eligible to start oral prep exclusion criteria: * unable to currently start prep * abnormal laboratory, medical, physical, or social finding which could impact study participation, by investigator discretion * unwilling or unable to provide informed consent * participating in another prep trial * unwilling to provide at least 2 forms of contact for follow-up * taking renal toxic medications * sexual partner known to be hiv-positive

Keywords: prep hiv smartphone